| 主权项 |
1. A modified release aqueous oral liquid suspension comprising:
(A) a particulate diffusion barrier coated, drug-ion exchange resin complex-matrix which comprises
(i) a particulate matrix comprising a particulate drug-ion exchange resin complex and a water insoluble polymer or copolymer or a hydrophilic polymer, said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix capable of passing through a number 40 mesh screen, said particulate drug-ion exchange resin complex comprising multiple drugs bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said water insoluble polymer or copolymer, or hydrophilic polymer, is present in said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix in an amount of about 3% to about 30% by weight, based on the weight of said particulate drug-ion exchange resin complex, and
(ii) a cured high tensile strength, water permeable, water insoluble, non ionic polymeric diffusion barrier coating over said particulate drug-ion exchange resin complex (water insoluble polymer or copolymer or said hydrophilic polymer) matrix in (i), said cured aqueous based barrier coating comprising:
(a) about 70% w/w to about 90% w/w polyvinylacetate polymer,(b) a stabilizer, and(c) about 2.5 to about 20% w/w of plasticizer effective to enhance the tensile strength of said cured barrier coating, whereby said cured coating provides about a twelve hour release profile to the drug in said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix, wherein the weight percentage is based on the weight of the cured barrier coating layer, wherein said multiple drugs in said coated drug-ion exchange resin complex-matrix comprise (i) codeine and (ii) chlorpheniramine or dexchlorpheniramine and optionally (iii) pseudoephedrine; (B) an uncoated particulate drug-ion exchange resin complex which comprises multiple drugs bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said multiple drugs in said uncoated drug-ion exchange resin complex comprise (i) codeine and (ii) chlorpheniramine or dexchlorpheniramine and optionally (iii) pseudoephedrine; (C) multiple drugs which are not complexed with an ion exchange resin, wherein said multiple drugs comprise (i) codeine, (ii) chlorpheniramine or dexchlorpheniramine and optionally (iii) pseudoephedrine; and (D) a pharmaceutically acceptable aqueous suspension base, wherein said components (A), (B) and (C) are in said aqueous base. |
